Needle protection device for use with a vial

ABSTRACT

A needle protection device for a vial, or capsule, has a housing hingedly or flexibly connected to a needle collar by a hinge. The collar has a main portion configured to fit about at least a portion of the body of the vial and an extension configured to fit about at least a portion of the neck of the vial. A needle hub, movable along the neck of the vial and to which a needle extends, is interposed between the body and neck of the vial. The hub has a skirt portion that could be moved along the neck of the vial for capping or overlapping the extension of the collar to thereby non-removably secure the collar to the vial. An improved syringe assembly is effected when a vial of the instant invention is placed within a vial holder applicator, such as for example a CARPUJECT applicator. Once firmly positioned within the applicator, a mechanism integral to the applicator is actuated to move the skirt portion of the hub and the collar extension that fits about the neck of the vial relatively towards each other so that the collar extension is capped by the hub skirt portion, thereby securely coupling the collar to the vial. A rod movable along the length of the applicator is mated with a plunger movable along the body of the vial to effect the syringe assembly. The housing hingedly connected to the collar is pivotable relative to the vial to envelop the needle extending from the hub, thereby ensuring that the needle, once contaminated, is prevented from being further exposed.

RELATED APPLICATIONS

This application is related to patent application Ser. No. 09/227,819now U.S. Pat. No. 6,334,857 filed Jan. 11, 1999 entitled “NeedleProtection Apparatus Used With A Vial”, assigned to the same assignee asthe instant application. The disclosure of the '819 application isincorporated by reference to the instant application.

FIELD OF THE INVENTION

The present invention relates to needle protection devices, and morespecifically a needle protection device that could securely couple to avial having a needle extending therefrom for preventing the needle, oncecontaminated, from being further exposed to the environment.

BACKGROUND OF THE INVENTION

A needle protection device for use with a vial that contains medicamentto be used with applicators such as the TUBEX and CARPUJECT applicatorsis disclosed in the aforenoted related '819 application. One embodimentof the related device disclosed in the '819 application has a collarthat slidably fits over the hub of a vial and secures thereto by meansof a number of extending fingers. Another embodiment of the '819 devicehas an open collar that mounts about the vial. A pair of interlockingextensions from the collar coact to secure the collar about the vial.Although work well, these devices fail to take full advantage of thestructure of the vial itself and the interaction between the vial andthe applicator in order to securely couple the needle protection deviceto the vial.

SUMMARY OF THE INVENTION

The present invention needle protection device is to be used with a vialor capsule that has a body and a neck extending therefrom. The vial hasa needle hub either interposed between the neck and the body of the vialor fitted over the neck of the vial. A needle extending from the hub isfluidly connected to the vial. The needle hub has a skirt portion thatis movable along the neck of the vial.

The needle protection device of the instant invention has a needleprotection housing hingedly or flexibly connected to an open endedcollar. The collar has a main portion that fits about at least a portionof the body of the vial, and an extension that fits about at least aportion of the neck of the vial.

To couple the collar to the vial, with the needle hub, and the skirtportion thereof, moved as far away from the body of the vial asfeasible, the collar of the needle portion housing is snap fitted aboutthe body and the neck of the vial. Once the collar is thus fitted to thevial, the hub fitted over the neck of the vial is moved towards the bodyof the vial, so that the skirt portion thereof caps or overlaps theextension of the collar fitted about the neck of the vial. When thuscapped, the collar, and therefore the needle protection housing, issecurely coupled to the vial. Thereafter, to prevent the needle thatextends from the vial from being exposed to the environment, the housingonly needs to be pivoted, relative to the collar, to the longitudinalaxis of the vial, to thereby envelop the needle extending from the vial.

An improved syringe assembly is effected when a vial fitted with theneedle protection housing as described above is placed in a vialapplicator, such as for example a CARPUJECT applicator. Once firmlyseated within the cavity of the vial applicator, a mechanism integral tothe applicator is actuated to apply a biasing force against the body ofthe vial to force the skirt portion of the needle hub and the collarextension to move relatively towards each other, with the end resultbeing that the collar extension is capped by the hub skirt portion,thereby firmly coupling the needle housing to the vial, which in turn isheld by the biasing force within the cavity of the holder applicator. Touse, a rod movable along the length of the applicator is mated to aplunger seal or gasket that is movable within the body of the vial foreffecting a plunger, which, when pushed, will cause the medicamentstored in the vial to be ejected out of the needle. Once used, theneedle is prevented from being further exposed by being enveloped by theneedle housing of the syringe assembly.

It is therefore an objective of the present invention to provide a vialsecurely fitted with a needle protection housing.

It is yet another objective of the present invention to provide animproved syringe assembly made up of a vial, a needle protection housingsecurely coupled thereto, and a holder applicator into which the vial issecurely held.

It is still another objective of the present invention to provide aneedle protection housing that could be retrofitted to existing vials orcapsules in which medicament may be stored.

BRIEF DESCRIPTION OF THE FIGURES

The above-mentioned objectives and advantages of the present inventionwill become apparent and the invention itself will be best understoodwith reference to the following description of embodiments of thepresent invention taken in conjunction with the accompanying drawings,wherein:

FIG. 1a is a top view of the needle protection device of the presentinvention, the housing of the device being positioned at right anglerelative to the collar of the device to which it is flexibly or hingedlyattached;

FIG. 1b is an end view illustrating the hook in the housing of FIG. 1a;

FIG. 1c is a cross-sectional view of the FIG. 1a housing;

FIG. 1d is a side view of the FIG. 1a device;

FIG. 1e is a front view of the collar of FIG. 1a;

FIG. 1f is an end view of the FIG. 1d device;

FIG. 1g is a perspective view of the collar of the instant inventiondevice showing an opening along the circumference of the collar;

FIG. 2 is an illustration of the inter-relationship among the device ofFIG. 1a, a vial to which the device is affixed, and a holder applicatorfor use with the vial;

FIG. 3 is an illustration of the improved syringe assembly of thepresent invention, sans the housing; and

FIG. 4 is a semi-exposed partial view illustrating the interrelationshipbetween the vial, the collar sans its housing that fits about the vial,the needle hub that fits over the neck of the vial, and the holderapplicator whereinto the vial is placed.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

With reference to FIGS. 1a-1 d, a needle protection device 2 of theinstant invention is shown to include a collar 4 and a needle housing 6movably connected thereto by means of a flexible hinge 8. As best shownin FIGS. 1e-1 g, collar 4 is structured in the form of a non-fullyclosed ring, an opening 14 along its circumference providing the breakto the collar. Collar 4 is further shown to have a main portion 4 a andan extension 4 b. The respective dimensions of portion 4 a and extension4 b are configured to form fit about the corresponding body and neck ofa vial, such as for example vial 16 shown in FIGS. 2 and 3.

Housing 6 of device 2 has formed along the length thereof a longitudinalslot 12 wherethrough a needle, such as for example needle 26 shown inFIGS. 2 and 3, passes. As shown in FIG. 2, needle 26 is enveloped byhousing 6 when the latter is pivoted in the direction designated byarrow 17 to a position along the longitudinal axis of vial 16, or needle26.

To prevent relative movement between needle 26 and housing 6, a lockingmeans is provided to housing 6 to fixedly retain needle 26 withinhousing 6 once needle 26 is enveloped by housing 6. Such locking meanscould be for example a latch or a hook 18 integrated to the inside ofhousing 6 that fixedly grasps needle 26 once finger 18 a of hook 18snaps over needle 26, as housing 6 is pivoted into alignment along thelongitudinal axis of vial 16.

With reference to FIGS. 2 and 3, vial 16 about which needle protectiondevice 2 is fitted is shown to include a main body 16 a, a neck 22extending from body 16 a, and a needle 26 extending from and in fluidcommunication with neck 22. As is well known, a needle hub 20 covers theproximal end of needle 26. Hub 20 has a base 20 a that covers and sealsneck 22 of vial 16. In practice, needle 26 is molded to and extends fromhub 20 so as to be in fluid communication with the medicament stored invial 16. Vial 16 is sealed at its other end by an elastomeric gasket 24that is movable along its interior circumferential wall 16 a. A screw 28is molded to gasket 24 to provide connection thereto.

As best shown in FIGS. 2, 3, and 4, base 20 a extends from needle hub20. Note that base 20 a has a large cross-sectional area than that ofthe main body of hub 20. As a consequence, a void exists between neck 22of vial 16 and base 20 a of hub 20. In other words, base 20 a forms askirt that overlaps neck 22 of vial 16. This space provided by base 20 ais of a dimension sufficient to fit over extension 4 b of collar 4, asbest shown in the semi-exposed partial view of FIG. 4. For the sake ofsimplicity in the understanding of the invention, housing 6, which inactuality is flexibly connected to collar 4, is not shown in FIG. 4.

During the manufacturing process of a vial such as for example vial 16as shown in the figures, the inventor has found that hub 20 is notfixedly mounted to neck 22 of vial 16. Rather, hub 20 is non-fixedlycoupled to neck 22 such that it is movable longitudinally relative toneck 22 of vial 16. Seizing onto this relationship between the needlehub and the vial, the inventor has designed collar 4 into the particularshape and structure as described herein so as to take full advantage ofthe relationship between hub 20 and neck 22 of the vial 16. That is, aswas mentioned previously, collar 4 is designed to have a main portion 4a that form fits about a portion of the main body of vial 16 and anextension 4 b that form fits about at least a portion of neck 22 thatextends from the main body of vial 16.

To secure device to vial 16, collar 4 is snap fitted about vial 16. Thisis possible because collar 4 is made of a plastic material that has agiven amount of flexibility so that collar 4 on either side of opening16 would flex to accept and then embrace vial 16, as collar 4 firstflexes and then returns to its original state. At the same time,extension 4 b of collar 4 likewise form fits about at least a portion ofneck 22. Once collar 4 is fitted about vial 16, hub 20 may be moved inthe direction towards the main body of vial 16 so that its base skirtportion 20 a caps over extension 4 b of collar 4 per directional arrow21 as shown in FIG. 4. As a consequence, collar 4, and therefore device2, is securely coupled to vial 16.

Also shown in FIGS. 2 and 3 is a holder applicator 30, represented forexample by a conventional CARPUJECT applicator, wherein vial 16 could befitted. Holder 30 includes an elongated housing 32 having a cavity 33.One side of housing 32 is opened to the environment and an aperture 34is formed at its opposing side. Housing 32 further has an opening 52 atone of its ends and a finger grip base 44 formed its other end. A boreextends through base 44.

Inserted through the bore of base 44 is a cylinder 42 that extends froma base 46 of substantially similar shape to grip 44. Cylinder 42 has agroove 36 that mates with a bump protrusion (not shown) formed at asurface of the bore of base 44 for guiding cylinder 42 when it is turnedin sync with the rotation of base 46. When cylinder 42 is turned toeither of its two extreme end positions, absent an external force, it islocked into position by the bump protrusion.

A bore, not shown, extends along the length of cylinder 42. A rod 48,freely coupled to base 46 through the bore of cylinder 42, is movablealong the length of holder 30. Rod 48 has a head 38 with a threadedportion 40 formed therein for mating with screw 28 extending fromsealing gasket 24 of vial 16.

Base 46, together with cylinder 42 extending therefrom, forms anactuable mechanism for securely maintaining vial 16 within holder 30 andfor non-removably securing protection device 2 to vial 16. Bothobjectives are achieved as follows.

Housing 32 is prepared to accept vial 16. To do that, base 46 is turnedcounterclockwise (or clockwise) to its lowermost position so as to lowera substantial portion of cylinder 42 into the bore of finger grip base44. Vial 16 is then placed into cavity 33 of housing 32, with opening 52providing access for needle 26, and hub 20, extending from vial 16 toextend beyond holder 30. Thereafter, base 46 is turned in a counterdirection to raise cylinder 42 towards vial 16. With base 46 turned toits extreme position, the top of cylinder 42 not only comes into contactwith the lowermost end of vial 16, but it also forces the uppermostportion of vial 16 into contact with shoulder 35 of housing 32. See FIG.4. As a consequence, a biasing force is applied against vial 16 andparticularly against neck 22 thereof by the underside of shoulder 35.

In view of the fact that neck 22 of vial 16 is covered by hub 20, thebiasing force against vial 16 in fact is applied against hub 20, therebyforcing hub 20 to move towards the main body of vial 16. As a result,skirt portion 20 a of hub 20 overlaps extension 4 b of collar 4. Puttingit differently, extension 4 b of collar 4 is capped by skirt portion 20a of hub 20 so that collar 4 is securely coupled to vial 16, and vial 16in turn is securely held within cavity 33 of holder 30.

Line 50 of FIG. 2 illustrates how vial 16, with needle protection device2 already fitted thereto, is fitted within cavity 32 of holder 30 toeffect the needle protection syringe assembly of FIG. 3.

The syringe assembly of FIG. 3 operates as follows. With vial 16properly fitted to holder 30, and hub 20 being biased against neck 22 ofvial 16, rod 48 of holder 30 is mated to plunger 24 of vial 16 bythreading portion 38 of rod 48 to screw 28 of gasket 24. The combinationof rod 48 and plunger 24 thus effects a plunger means for enabling themedicament stored in body 16 a of vial 16 to be ejected through needle26. This is done by rod 48 pushing gasket 24 towards neck 22 of vial 16for ejecting the medicament out of needle 26.

Note that a vial absent the hub structure as described above may also beused to effect the syringe assembly of the instant invention. It isenvisioned that a collar such as collar 4 discussed above is molded toform fit the neck of such hubless vial, i.e., body 4 a fitting about thebody 16 while extension 4 b form fitting about a portion of neck 22 ofvial 16. The collar is then acted upon by the same biasing force asdiscussed above, so that collar 4 is sandwiched between shoulder 35 ofhousing 32 and neck 22 of vial 16 so as to be securely held in placethereby. For this embodiment, shoulder 35 of housing 32 may beconfigured to have a slight concave portion for capping extension 4 b ofcollar 4. Without saying, a housing protection housing such as 6 ispivotally connected to collar 4.

Once vial 16 is properly fitted to holder 30 and collar 4 securelycoupled and held in place, to operate, a patient is pricked with needle26. Rod 48 of holder 30 is then pushed, thereby causing gasket 24 tomove along vial 16 to forceably eject the medicament stored in vial 16through needle 26 into the patient. Afterwards, needle 26 is withdrawnfrom the patient and housing 6 is pivoted to align along thelongitudinal axis of vial 16 to envelop needle 26. As needle 26 is beingenveloped by housing 6, finger 18 a of hook 18 snaps over needle 26 tothereby fixedly retain needle 26 within housing 6. Portion 40 of rod 48could then be unthreaded from screw 28 of gasket 24, and base 46 turnedto lower cylinder 42 away from vial 16, to thereby release its biasingforce on vial 16. Vial 16 could then be removed from holder 30 anddiscarded.

It should be appreciated that the present invention is subject to manyvariations, modifications, and changes in detail. For example, eventhough the syringe assembly of the instant invention has been describedas being used to inject a patient with medicament stored in the vial, itcould very well be that the vial is empty when it is fitted to theapplicator, so that instead of being used for ejection, the syringeassembly of the instant invention could be used for withdrawing bodyfluid from a patient. Irrespective of how the syringe assembly of theinstant invention is to be used, the fact remains that each vial of theassembly is securely fitted with a collar that has pivotally attachedthereto a needle protection housing for enveloping a contaminatedneedle. Thus, all matter described throughout this specification andshown in the accompanying drawings should be interpreted as illustrativeonly and not in a limiting sense. Accordingly, it is intended that thisinvention be limited only by the spirit and scope of the hereto appendedclaims.

What is claimed is:
 1. In combination, a vial having a neck, a hubmounted about said neck, a needle extending from said hub, a collarfifted about said vial, said collar having an extension that fits aboutthe neck of said vial, a holder for accepting said vial, a mechanismworking cooperatively with said holder for maintaining said vial in saidholder, said mechanism actuable to apply a biasing force against saidhub, said hub having a skirt portion that, when biased by said force, isdriven to overlap said extension of said collar to thereby fixedlycouple said collar to said vial.
 2. Combination of claim 1, furthercomprising: a housing movably coupled to said collar, said housingpivotable to a position in alignment along the longitudinal axis of saidvial to envelop said needle.
 3. Combination of claim 1, furthercomprising: locking means integrated to said housing for preventing saidneedle and said housing from moving away relative to each other oncesaid housing is pivoted to envelop said needle.
 4. Combination of claim1, wherein said holder comprises an elongated member having a cavitywhereinto said vial is placed, said holder further having respectiveopenings at both of its ends, one of said openings for providing accessfor said needle to extend beyond said holder, the other of said openingsproviding a path for a rod to extend from outside of said holder towithin the interior of said vial to mate with a plunger movably fittedwithin said vial; wherein when said rod is pushed towards the neck ofsaid vial, said plunger forces any medicament stored in said vial to beejected through said needle.
 5. Combination of claim 1, wherein saidmechanism comprises a turnable base that, when rotated to one direction,would come into contact with the end of the body of said vial away fromsaid neck for applying a force against said vial to thereby indirectlyapply said biasing force against said hub.
 6. Apparatus, comprising: avial having a body, a neck extending from said body and a needleextending from said neck; a housing for enveloping said needle, saidhousing having a collar that is configured to fit to said vial, saidcollar having a portion that is adapted to clamp about said body of saidvial and an extension that is adapted to fit about at least a portion ofthe neck of said vial; wherein said vial has a needle hub having a skirtportion covering and movable along said neck, and wherein said extensionof said collar is fitted to said neck of said vial so that said skirtportion overlaps said extension of said collar for fixedly coupling saidcollar to said vial once said collar and said extension are fitted tosaid vial and its neck, respectively, and said skirt portion of said hubis moved to overlap said extension.
 7. A method of attaching a needleprotection housing to a vial having a body, a neck extending from saidbody and a needle extending from said neck, a hub having a skirt portionthat is movable along said neck of said vial, comprising the steps of:a) integrating a collar to said housing, said collar having a portionthat clamps about the body of said vial and an extension that fits aboutat least a portion of said neck of said vial; b) securing said housingto said vial by means of said collar; and c) moving said hub to positionsaid skirt portion to overlap said extension of said collar.
 8. Methodof claim 7, wherein said step a further comprises the step of: attachingsaid housing to said collar via a hinge, said housing pivotable aboutsaid hinge to a position along the longitudinal axis of said vial toenvelop said needle.
 9. Method of claim 7, wherein said step b furthercomprises the step of: fitting said collar to said vial via an openingat a location along the circumference of said collar.
 10. Method ofclaim 7, further comprising the steps of: placing said vial secured withsaid collar into a holder, said holder having one end for biasingagainst the neck of said vial and a mechanism for applying a biasingforce against the other end of the body of said vial away from saidneck; and actuating said mechanism to apply a force against said otherend of the body of said vial to push said vial towards said one end ofsaid holder to thereby move said skirt portion and said extensionrelatively towards each other until said skirt portion overlaps saidextension of said collar for fixedly coupling said collar